Number of Participants Who Died or Experienced Other Serious Adverse Events (SAEs) [ Time Frame: From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing). Participants were monitored for SAEs up to 30 days after study discharge. ] [ Designated as safety issue: Yes ]

An SAE was defined as any adverse event (AE) occurring at any dose that; resulted in death; was life threatening; resulted in a persistent or significant disability/incapacity; resulted in/prolonged an existing in-patient hospitalization; was a congenital anomaly/birth defect; was a cancer; or was an overdose.

Number of Participants Who Experienced AEs [ Time Frame: From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing). ] [ Designated as safety issue: Yes ]

AEs were defined as any new untoward medical occurrences or worsening of a pre-existing medical condition in a participant administered a medicinal product, whether or not considered related to the medicinal product.

Number of Participants Who Experienced AEs Leading to Study Drug Discontinuation [ Time Frame: From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing). ] [ Designated as safety issue: Yes ]

AEs were defined as any new untoward medical occurrences or worsening of a pre-existing medical condition in a participant administered a medicinal product, whether or not considered related to the medicinal product. Participants who discontinued the study due to an AE were recorded.

Number of Participants With Marked Abnormalities (MAs) in Hematology Measurements [ Time Frame: Throughout study, from screening (within 21 days of Day 1 dosing) through Day 3. ] [ Designated as safety issue: Yes ]

Number of Participants With Urinalysis MAs [ Time Frame: Throughout study, from screening (within 21 days of Day 1 dosing) through Day 3. ] [ Designated as safety issue: Yes ]

MAs are laboratory measurements marked as abnormal, per pre-defined study criteria, at any study time point. The following urinalysis MA definitions specify the criteria for MAs in the data presented. The presence of white blood cells (WBCs) and red blood cells (RBCs) in the urine was graded on a scale: 0 = no cells present (negative); trace =a small number of cells present; then 1+, 2+, 3+ and 4+, denoting increasingly "positive" urine results (ie, WBCs/RBCs present in the urine). The MA for both WBCs and RBCs was >= 2+ (or, if pre-treatment value >=2+, then >= 4+).

Number of Participants With Identified Electrocardiogram (ECG) Abnormalities [ Time Frame: From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing) ] [ Designated as safety issue: Yes ]

ECG abnormalities are findings that are clinically meaningful by the judgment of the investigator. A 12-lead ECG was performed and all ECG recordings were evaluated by the investigator. Abnormalities, if present at any study time point, were listed.

Number of Participants With Clinically Meaningful Vital Signs Measures [ Time Frame: From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing) ] [ Designated as safety issue: Yes ]

Vital signs were recorded throughout the study and included investigations related to body temperature, respiratory rate, seated blood pressure (systolic and diastolic), and heart rate. The investigator used his/her clinical judgement to decide whether or not abnormalities in vital signs were clinically meaningful.

Number of Participants With Abnormal Physical Examination Findings at Baseline (Screening and/or Day 1) [ Time Frame: From screening (within 21 days of Day 1 dosing) to the study discharge day (Day 2 for AM dosing or Day 3 for PM dosing) ] [ Designated as safety issue: Yes ]

The physical examination included an evaluation of the participant's height and body mass index (BMI) (at screening only), and weight. Abnormal physical examination are findings that are clinically meaningful by the judgment of the investigator

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Please refer to this study by its ClinicalTrials.gov identifier: NCT00162097